Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Reported: January 31, 2024 Initiated: December 26, 2023 #Z-0788-2024
Product Description
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Reason for Recall
Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to turn on the device, or an unexpected shutdown, which is a momentary loss of power to the knee where the user may experience loss of support that can lead to a fall and potential injury.
Details
- Recalling Firm
- Ossur H / F
- Units Affected
- 544 Batteries
- Distribution
- US Nationwide distribution including in the states of MA, SC, MD, TN, ND, VA, IL, NJ, FL, MI, NY, AL, TX, OK, IN, GA, CA, PA, NM, VT, NV, MS, HI, OH, WI, LA, IA, NE, MN, AR, OR, NC, NH, WV, CO, ID, AZ, MO, CT, WA, KY, UT, KS.
- Location
- Reykjavik, N/A
Frequently Asked Questions
What product was recalled? ▼
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002. Recalled by Ossur H / F. Units affected: 544 Batteries.
Why was this product recalled? ▼
Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to turn on the device, or an unexpected shutdown, which is a momentary loss of power to the knee where the user may experience loss of support that can lead to a fall and potential injury.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 31, 2024. Severity: Moderate. Recall number: Z-0788-2024.
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